NCT00403819

Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

A Phase III Multi-Centre Placebo-Controlled Crossover Study Followed by an Open Label Post-Study Follow-up to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 24 Months – 11 Years
• Healthy volunteers: Not accepted

Summary

A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety of Movicol in the treatment of chronic constipation in children

Detailed description

After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were entered into the treatment phase of the study. Patients were randomised to receive either Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients underwent a two (2)-week placebo washout period prior to crossing over to receive the alternative treatment e.g. those patients who took Movicol were given the matching Placebo or vice versa on completion of the washout period for two (2) weeks. On completion of the double blind treatment phase, patients were given the option to participate in the eight (8) week open label post study follow-up. Patients who participated in the post study follow-up received Movicol.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DRUG	Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)

Timeline

• Start date: 2002-04-01
• Completion: 2003-04-01
• First posted: 2006-11-27
• Last updated: 2006-11-28

Locations

6 sites across 1 country: United Kingdom